Food and Drug Regulations; Too Many, Too Few, or Just Enough?


In light of the recent and well publicized drug shortages, the national debate on healthcare costs, and the slowing pace of new drug approvals, we felt the American consumer might appreciate a blog dedicated to the current relationship between drug manufacturers, the FDA, and Title 21.

Federal Regulations and Consumer Protection: A Primer for the American People

The U.S. Department of Health and Human Services (HHS) was established to enforce Federal Regulations designed to protect the health and safety of those in the United States (e.g., The Food Drug and Cosmetic Act/Title 21 under the supervision of the Food and Drug Agency, and the group of Acts under the supervision of the Environmental Protection Agency).

Title 21 regulations, which we will focus on today, are designed to protect public health by primarily:

  • Promoting the quality, purity, and safety of products
  • Encouraging innovation while reducing costs
  • Avoiding shortages of critical medicinal products and therapies

The scope of Title 21 includes:

  • processed food – human and animal
  • pharmaceuticals and bio-pharmaceutical products – for human and veterinary use
  • medical devices – for human and veterinary use
  • medical and surgical procedures
  • radiation emitting devices
  • cosmetics
  • tobacco

The Collaborative Model

The legislative branch of the US federal government constructs applicable regulations and the executive branch creates and administers agencies to enforce those laws. However, the practice of protecting the American consumer must be a collaborative model that includes the private sector, governmental agencies, and consumers, each bearing a portion of the responsibility.

Those responsibilities include:

Private Sector Manufacturers:

    • Pre-market – prove that the candidate product is safe, pure, and effective
    • Post market – produce the product within controllable and measureable bounds, in accordance with standards and specifications
    • Report and investigate failures
    • Maintain mechanisms that allow consumers to report complaints, and to report those complaints to the government
    • Voluntarily recall a product if it is not produced within a state of control


    • Congress – refine regulations to improve productivity and reduce compliance burdens, respond to trends, assess the size of and fund the FDA appropriately
    • FDA – inspect manufacturing sites routinely, evaluate, refine, and improve inspection methods, monitor and track complaints, adverse events, and voluntary recalls, assess inspection results thoroughly, train inspectors well, and provide public safety statements


    • Educate themselves with regard to Title 21
    • Research products
    • Report adverse effects or unexpected observations to manufacturers or pharmacies

Protection and Promotion: A Delicate Balance

While each of these groups plays an individually critical role in what appears to be a neatly integrated model, balancing these components to realize comprehensive protection (steady, low cost, and safe supply) of the consumer is anything but simple.

Take, for instance, the mandate of Title 21 and the FDA; the regulations and the regulators attempt to protect the public from bad product – but also to protect the public from a shortage of quality product.

Perspective with Purpose: Quality with Clarity’s December 2011topic featured just one of the challenges faced or created by the current regulations that attempt to meet competing objectives; creating a regulatory system that both promotes innovation and reduces consumer cost.

This month, we feature an equally challenging feature of the consumer protection mandate. How do we create a regulatory framework that will be capable of identifying poor quality product and prevent it from reaching the market place while continuing to ensure that critically necessary products are consistently available to the public?

As Pharma companies continue to grow in size and scope, a single company may be the supplier of dozens of critical products. Is our current regulatory framework capable of surgically targeting a single lot of a single product line, or even every lot of a single product line, without harming the manufacturer’s ability to maintain the supply of all of their other products?

The answer is not clear and is currently being debated across the private sector and at the highest levels of government. What is clear is that the number of drug shortages is on the increase, the number of new drug approvals is on the decrease, and the cost of available therapies is most certainly rising.


Our Current Climate – Over Regulated, Under Regulated, or Inefficiently Regulated?

For those of you that believe we are under regulated or over regulated, let’s take a closer look at some steps in the evolution of our regulatory framework and examine a few unintended consequences of federal regulations over time:



This is by no means a complete list. In actual fact, what we know today as the FDA has its origin in the Department of Agriculture, created in 1862 by President Lincoln in response to the risks posed by early American industrial farmers and meat packers/transporters. This table is meant to look only into some of the most transformational acts of Congress that have had immediate impact on the nature of the market place. The reality is that since the inception of the modern FDA in 1930, Acts of Congress have altered the model multiple times per decade. Title 21 and the role of the FDA are routinely tweaked in response to the evolution of the market place, consumer needs, technological advances and, as noted in the table above, in response to the unintended consequences of previously implemented laws.

When we review even these few examples, we can see that even with the best intentions, often times the protections we seek from law pose dangers that were not intended. Our past response to this has been to issue a new regulation to preserve what was useful in the last and mitigate the impact of what was harmful.

Whether you feel that the current regulatory frame work goes too far, or not far enough, it is clear that when regulations are devised to influence the market, the outcome can never be completely predicted.

While these regulations have had a positive impact on the safety and purity of drug products, consider this sample of recent and negative consequences:

Federal efforts to incentivize competition did:

  • not reduce overall costs to the consumer
  • spur growth of mega-companies that avoided risking capital in research by choosing instead to buy smaller companies
  • reduce incentive to develop therapies for small and poor markets

Increasing the scope of the regulations and the power of regulators did:

  • Incentivize manufacturers to move operations overseas
  • Increase the technical complexity in compliance and remediating observed issues, which many would argue have:

o contributed to drug shortages for the manufacturers of finished pharmaceuticals:

        • according to the White House, the number of reported prescription drug shortages in the United States has nearly tripled between 2005 and 2010
        • currently FDA reports shortages of 200 medically necessary medications (drugs for which substitute drugs are not available). The current list includes cancer drugs, anesthetics, sterile injectables (cardiac and antibiotic), vaccines, and intravenous nutrition therapies.

o endangered the supply chain of large numbers of manufacturers if the compliance issues are at the supplier level

Increasing the scope of FDA responsibilities did:

  • Slow the pace of product approval

Summary: As Consumers, What Should We Expect?

The rules and regulations collectively known as Title 21 of the Code of Federal Regulations have been implemented to ensure the health and safety of the American consumer. As consumers, we should expect, at the very least, that these laws ensure that drug product and medical procedures (as well as our food supply) are:

  • Safe
  • Pure
  • Of high and dependable quality

In addition to those expectations, and in light of the steady expansions of the law and the role and power of the agency that enforces them, it would not be unreasonable to expect that food and drug laws:

  • Do not raise the end cost to the consumer
  • Do not threaten the supply of the products
  • Do not interfere with the pace of medical research and eventual development

While there are many effective protections provided by Title 21, including:

  • Monitored clinical trials
  • Fast Track Approvals
  • Incentives to make niche drugs
  • Patents that expire
  • Pre Approval Inspections (PAIs) prior to licensing
  • GMPs during routine production
  • Routine system based inspections
  • Consumer driven adverse event reporting
  • Monitored voluntary recalls
  • Title 21 punitive options

the question remains, have we achieved the delicate balance required to protect health and human safety without setting the compliance bar so high that drugs become unavailable when we need them?


You decide.


While you are deciding, participate actively as a consumer in the system that can dramatically affect the health and safety of you and your family:

  • Take advantage of publically available information at
  • Follow legislative action and enforcement trends
  • Research medicinal therapies before you take them
  • Report any adverse effect of any drug you take
  • Support companies that support research
  • Demand that your government continue to seek mechanisms to achieve the balance between safety, availability, and progress by:

o critically assessing the impact of the regulations

o seeking innovative improvement


And finally, remember, this model was developed to be collaborative; we all have a role to play. Consumer protection is not the sole responsibility of government.


We are ALL a part of the solution.


© Coda Corp USA 2015. All rights reserved.




Gina Guido-Redden

Chief Operating Officer

Coda Corp USA

(p) 716.751.6150

[email protected]

“Quality is never an accident; it is the result of high intention, sincere effort, intelligent direction and skillful execution. It is the wisest of many alternatives.”


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